DRKS00012423已完成未知
Randomized comparison of two contemporary balloon devices in catheter ablation of atrial fibrillation - Cryoballoon versus Laserballon II
CCB Cardioangiologisches Centrum Bethanien, Markus Krankenhaus0 个研究点目标入组 200 人开始时间: 2017年6月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Paroxysmal and persistent atrial fibrillation with an episode duration of > 7 days and < 1 year or patients with electrical cardioversion > 48 h after atrial fibrillation episode onset
- •- Ineffective treatment with at least one antiarrhythmic drug (class I-III) or betablocker
- •- Age 18 - 80 years
- •- Left atrial size < 45 mm
- •- Left ventricular ejection fraction > 45 %
- •- Patient is able to provide informed consent
排除标准
- •- Contraindications for pulmonary vein isolation
- •- Previous pulmonary vein isolation attempts
- •- Inability to be treated with oral anticoagulation
- •- Presence of intracardiac thrombi
- •- Pregnancy
- •- Participation in other clinical studies
- •- Mitral regurgitation = III°
- •- Moderate mitral stenosis
- •- Unwilling to follow the study protocol and to attend follow-up visits
研究者
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